BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 10975528 · Received December 9, 2020

    Report

    Report Number
    2916596-2020-06071
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Date of Event
    August 5, 2020
    Report Date
    December 9, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A BACKUP BATTERY FAULT ALARM WAS CONFIRMED VIA THE SUBMITTED LOG FILE. THE LOG FILE CONTAINED APPROXIMATELY 9 DAYS OF DATA (28JUL2020 ¿ 06AUG2020 PER THE TIMESTAMP). THE LOG FILE CAPTURED A BACKUP BATTERY FAULT ALARM DUE TO A BACKUP BATTERY END OF SERVICE LIFE FAULT FROM 05AUG2020 AT 0:00:03 UNTIL THE BACKUP BATTERY WAS DISCONNECTED AT 11:21:23 ON 06AUG2020; THE PROVIDED INFORMATION INDICATED THAT THE BACKUP BATTERY WAS EXCHANGED AT THIS TIME. THE ALARM RESOLVED AFTER THE BACKUP BATTERY WAS CHANGED. NO OTHER NOTABLE ALARMS WERE ACTIVE IN THE LOG FILE. THE ALARM DID NOT AFFECT THE CONTROLLER¿S ABILITY TO OPERATE THE PUMP AT THE SET SPEED. ADDITIONAL INFORMATION PROVIDED STATED THAT THE SERIAL NUMBER OF THE EXCHANGED BACKUP BATTERY IS (B)(4), AND THAT THE EXCHANGED BATTERY WOULD NOT BE RETURNED FOR ANALYSIS. THE MANUFACTURE DATE OF THE BACKUP BATTERY IS 04AUG2017; THEREFORE, THE BATTERY WOULD BE EXPIRED AS OF 05AUG2020. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE THE BACKUP BATTERY BEING USED PAST THE EXPIRATION DATE. DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. HSC-002592 WAS SHIPPED TO THE CUSTOMER ON 27OCT2014 IN CUSTOMER ORDER S144602. THE 11V BACKUP BATTERY WAS ACCEPTED INTO STORAGE LOCATION ON 20SEP2017 PER MATERIAL DOCUMENT (B)(4). HEARTMATE 3 PATIENT HANDBOOK, UNDER SECTION 5 ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU), UNDER SECTION 7 ¿ALARMS AND TROUBLESHOOTING¿ COVER ALL ALARMS (VISUAL AND AUDIBLE), INCLUDING THE BACKUP BATTERY FAULT ALARM CONDITIONS, AND THE ACTIONS TO TAKE IF THE ALARMS CANNOT BE RESOLVED. HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) SECTION 5 ¿SURGICAL PROCEDURES¿, EXPLAINS HOW TO INSTALL THE BACKUP BATTERY IN THE SYSTEM CONTROLLER. SECTION 2 "SYSTEM OPERATIONS" EXPLAINS HOW TO REPLACE THE SYSTEM CONTROLLER BACKUP BATTERY. THIS SECTION ALSO STATES THAT THE BACKUP BATTERY HAS A LIMITED LIFESPAN OF 36 MONTHS FROM THE MANUFACTURE DATE. THEREFORE, IT MAY BE NECESSARY TO INSTALL A REPLACEMENT BACKUP BATTERY IF THE CURRENT ONE EXPIRES, OR IF PROMPTED BY A BACKUP BATTERY FAULT ALARM. SECTION 4 ¿SYSTEM MONITOR¿ INFORMS THE USER OF HOW TO VIEW THE BACKUP BATTERY INFORMATION ON THE SYSTEM MONITOR INFORMATION, INCLUDING THE NUMBER OF MONTHS LEFT UNTIL THE BACKUP BATTERY WILL NEED TO BE REPLACED, AND SECTION E ¿SAFETY CHECKLISTS¿ INFORMS THE HOSPITAL STAFF TO USE THE SYSTEM MONITOR TO CHECK THE EXPIRATION DATE AND BATTERY USAGE OF THE BACKUP BATTERY. HEARTMATE 3 PATIENT HANDBOOK AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) CAUTION USERS TO CALL THEIR HOSPITAL CONTACTS IF THEY THINK, FOR ANY REASON, ANY PORTION OF THEIR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR THEY ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SEEN FOR A YELLOW WRENCH ALARM. THE BATTERY WAS REPLACED AND THERE WERE NO ADDITIONAL CONCERNS. UPON REVIEW OF THE LOG FILE, THE REPORTED EVENT WAS DETERMINED TO BE DUE TO THE BACKUP BATTERY EXPIRING ON (B)(6) 2020, WHICH RESULTED IN THE CONTROLLER ALARMING FOR A BACKUP BATTERY FAULT ALARM AT MIDNIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446012 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106531

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR